scholarly journals Helical Tomotherapy for Inoperable Breast Cancer: A New Promising Tool

2013 ◽  
Vol 2013 ◽  
pp. 1-8 ◽  
Author(s):  
Ciprian Chira ◽  
Youlia M. Kirova ◽  
Xavier Liem ◽  
François Campana ◽  
Dominique Peurien ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Helical Tomotherapy ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Staging System ◽  
Skin Toxicity ◽  
Adequate Treatment ◽  
Promising Tool ◽  
Large Breast ◽  
Grade 3

Background. We investigated the feasibility of helical tomotherapy (HT) for inoperable large breast tumors, after failing to achieve adequate treatment planning with conformal radiation techniques.Material and Methods. Five consecutive patients with locally advanced breast cancer (LABC) were treated by preoperative HT. All patients received up-front chemotherapy before HT. Irradiated volumes included breast and nodal areas (45–50 Gy) in 4 patients. One patient received a simultaneous integrated boost (55 Gy) to gross tumor volume (GTV) without lymph node irradiation. Acute toxicity was assessed with Common Toxicity Criteria for Adverse Events v.4. Patients were evaluated for surgery at the end of treatment.Results. Patients were staged IIB to IIIC (according to the AJCC staging system 2010). HT was associated in 4 patients with concomitant chemotherapy (5-fluorouracil and vinorelbine). Two patients were scored with grade 3 skin toxicity (had not completed HT) and one with grade 3 febrile neutropenia. One patient stopped HT with grade 2 skin toxicity. All patients were able to undergo mastectomy at a median interval of 43 days (31–52) from HT. Pathological partial response was seen in all patients.Conclusions. HT is feasible with acceptable toxicity profiles, potentially increased by chemotherapy. These preliminary results prompt us to consider a phase II study.

Neoadjuvant dose-dense docetaxel, carboplatinum, and trastuzumab (ddTCH) chemotherapy for HER2 overexpressing breast cancer

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e11557-e11557 ◽  
Author(s):  
S. Bayraktar ◽  
U. D. Bayraktar ◽  
I. M. Reis ◽  
M. Pegram ◽  
C. Welsh ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Disease Free Survival ◽  
High Risk Group ◽  
Her2 Positive ◽  
Her2 Positive Breast Cancer ◽  
Grade 3 ◽  
Dose Dense ◽  
Positive Breast Cancer

e11557 Background: Neoadjuvant chemotherapy for locally advanced breast cancer was shown to improve the complete pathologic (pCR) and clinical response (cCR) as well as the disease free survival (DFS). Docetaxel, cisplatin, and trastuzumab given every 21 days in her2-positive breast cancer demonstrated a pCR rate of 23%. The concept of dose dense chemotherapy regimens has attracted much attention and we hypothesized that dose-dense regimen would further improve pCR, cCR and would maintain the safety profile while being a suitable regimen for outpatient administration. Methods: 48 patients with stage II/III HER2-positive breast cancer were prospectively enrolled on a clinical trial of a neoadjuvant regimen consisting of docetaxel 70 mg/m2 on days 1, 15, 29, and 43; carboplatinum at an AUC of 6 on days 1, 15, 29, and 43; trastuzumab 4 mg/kg on day 1 and 2 mg/kg weekly x 10 starting on day 8; peg-filgastrim 6 mg on days 2, 16, 30, and 44. Results: The median age was 50 years (range 30–78). 52% of patients were premenopausal, 63% and 22% were of Hispanic and African descent, respectively. Estrogen receptor was positive in 52% patients and median tumor size was 5 cm at the time of diagnosis. TNM stage distribution at presentation: T1 2%, T2 25%, T3 57%, T4 16%; N0 29%, N1 46%, N2 16%, N3 7%; M0 100%. pCR in breast; axilla; and both breast and axilla was observed in 19 of 44 patients (43.2%; 95% CI 28.3% - 59.0%); in 29 of 44 patients (65.9%; 95% CI 50.1% - 79.5%); and in 16 of 44 patients (36.4%; 95% CI 22.4% - 52.2%), respectively. No grade 4 or 5 toxicity occurred. The most frequent grade 3 toxicities were hand-foot syndrome (7%), neutropenia (4%), nausea/vomiting (2%), and bone pain (2%). Grade 2 cardiotoxicity was seen in 8% of patients and no grade 3 cardiotoxicity was observed. Conclusions: This neoadjuvant regimen was well tolerated and yielded a good pCR rate for this high risk group of patients. No significant financial relationships to disclose.

Phase II open clinical trial to evaluate efficacy and safety of neoadjuvant trastuzumab in HER2-positive locally advanced breast cancer (LABC)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 592-592
Author(s):  
C. H. Arce-Salinas ◽  
F. U. Lara ◽  
E. Leon
Keyword(s):  
Breast Cancer ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Disease Free Survival ◽  
Complete Response ◽  
Her2 Positive ◽  
Primary Systemic Therapy ◽  
Her 2 ◽  
Grade 3

592 Background: LABC in Mexico represents between 50–60% of the new diagnosed cases, and 25–30% of those cancers are HER-2/neu positive. Primary systemic therapy trastuzumab-based combination chemotherapy (ChT) has shown clinical benefit and pathologic complete response rates are obtained between 17%-67%. The aim of this study was evaluate the complete pathologic response (pR) rate with the combination of four cyles of FAC (5FU/Doxorubicin/Cyclophosphamide) followed by weekly paclitaxel (PTX) and trastuzumab. As secondary endpoint was evaluate cardiac safety. Methods: All patients with LABC HER-2 positive (IHC 3+ or FISH amplification) with stages IIb-IIIc were included, patients with palpable nodes underwent fine needle aspiration to confirm metastatic nodal disease (MND), other inclusion criteria was FEVI ≥55% determined by MUGA, hematologic, renal and hepatic function normal. We exclude inflammatory breast cancer. All patients received 4 cycles of FAC followed by weekly PTX (80 mg/m2) concomitantly with trastuzumab, 2 mg/kg, at the end of treatment surgery was performed, and pR was evaluable. Complete pR was defined as the absence of tumor cells in breast and axillary nodes. Disease free survival (DFS) was calculated with Kaplan-Meier method. Protocol was approved by local ethical committee. NCT 00533936. Results: We included 92 patients, median age was 48 (27–68) yrs. Median tumor size was 6 (5.4–6.5) cm, 84.9% had MND. Efficacy analysis was made in 71 patients; 21 patients are still under treatment. Overall clinical response was reached in 71% (complete 37% and partial 42%). Eleven patients were considered inoperable (skin affection, larger size > 5 cm or fixed to chest wall and received radiotherapy 50 Gy). Complete pR was reported in 48% of cases. Median follow-up was 17.4 (CI95% 14.9, 17.6) mo and media of DFS was 25.1 (CI95% 23.5, 26.7) mo. We found cardiac toxicity (CT) grade 3 in 1.1%, and grade 2 in 3.2%. Conclusions: Combination of PTX and trastuzumab after 4 cycles of FAC is highly active in terms of complete pR. This scheme was tolerated, with CT grade 3–4 in less than 2%. No significant financial relationships to disclose.

scholarly journals Nanoparticle albumin-bound paclitaxel in a patient with locally advanced breast cancer and taxane-induced skin toxicity: a case report

2014 ◽  
Vol 8 (1) ◽  
Author(s):  
Beatriz Cirauqui Cirauqui ◽  
Vanesa Quiroga García ◽  
Clara Lezcano Rubio ◽  
Maria Iciar Pascual Miguel ◽  
Laia Capdevila Riera ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Case Report ◽  
Advanced Breast Cancer ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Skin Toxicity ◽  
Advanced Breast

Phase II Clinical Trial of Ixabepilone (BMS-247550), an Epothilone B Analog, in Metastatic and Locally Advanced Breast Cancer

2005 ◽  
Vol 23 (12) ◽  
pp. 2726-2734 ◽  
Author(s):  
Jennifer A. Low ◽  
Suparna B. Wedam ◽  
James J. Lee ◽  
Arlene W. Berman ◽  
Adam Brufsky ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Phase Ii ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Sensory Neuropathy ◽  
Microtubule Stabilization ◽  
Epothilone B ◽  
Grade 3 ◽  
Tumor Biopsies

Purpose Ixabepilone (BMS-247550) is an epothilone B analog that stabilizes microtubules and has antitumor activity in taxane-refractory patients in phase I studies. In a phase II trial, we evaluated the efficacy and safety of ixabepilone in women with metastatic and locally advanced breast cancer. Patients and Methods Breast cancer patients with measurable disease who had paclitaxel and/or docetaxel as prior neoadjuvant, adjuvant, or metastatic therapy were treated with ixabepilone at 6 mg/m2/d intravenously on days 1 through 5 every 3 weeks. Levels of glutamate (glu) -terminated and acetylated α-tubulin, markers of microtubule stabilization, were detected by Western blot and by immunohistochemistry in a subset of matched pre- and post-treatment tumor biopsies. Results Thirty-seven patients received 153 cycles of ixabepilone. The best responses were a complete response in one patient (3%), partial responses in seven patients (19%), and stable disease in 13 patients (35%). Grade 3 and 4 toxicities included neutropenia (35%), febrile neutropenia (14%), fatigue (14%), diarrhea (11%), nausea/vomiting (5%), myalgia/arthralgia (3%), and sensory neuropathy (3%). Two patients were removed from study because of prolonged grade 2 or 3 neurotoxicity, and three patients were removed from study for other grade 3 and 4 nonhematologic toxicities. Compared with baseline levels, levels of both glu-terminated and acetylated α-tubulin were increased in tumor biopsies performed after ixabepilone therapy. Conclusion An objective response was seen in 22% of the patients in a population who had been previously treated with a taxane. Sensory neuropathy was mild with grade 3 neurotoxicity rarely seen. Microtubule stabilization occurred in tumor biopsies after treatment with ixabepilone.

Inflammatory and locally advanced breast cancer respond similar to operable breast cancer to neoadjuvant chemotherapy: Results from 278 patients with cT4a-d tumors of the GeparTRIO trial

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 542-542
Author(s):  
G. Von Minckwitz ◽  
S. Kümmel ◽  
P. Vogel ◽  
C. Hanusch ◽  
H. Eidtmann ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Neoadjuvant Chemotherapy ◽  
Large Scale ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Tumor Stage ◽  
Breast Conserving Therapy ◽  
Non Invasive ◽  
Tumor Reduction ◽  
Grade 3

542 Background: Neoadjuvant chemotherapy is the treatment of choice in patients with T4a-c and inflammatory (T4d) breast cancer. However, data on large-scale, multicentre, prospective trials are missing. In the GeparTRIO study (SABCS 2006, abstr. 42) 278 of 2,090 patients with cT4a-c or T4d tumors were included as a separate stratum for inoperable disease for a prospectively planned analysis. Methods: Patients were treated with 2 cycles TAC (docetaxel 75 mg/m2, doxorubicin 50 mg/m2, cyclophosphamide 500 mg/m2, q d 21). If tumor reduction was >50%, patients were randomized to receive 4 or 6 additional TAC cycles. If tumor reduction was less, patients were randomized to 4 additional TAC cycles or to 4 NX cycles (vinorelbine 25 mg/m2 day 1 + 8, capecitabine 2,000 mg/m2 day 1 14, q21). Efficacy endpoints were pCR-rate (no invasive and no non-invasive residuals in breast and lymph nodes) (primary), clinical response before surgery and breast conserving therapy (BCT) rate (secondary). Results: 95 (4.6%) T4d, 183 (8.9%) cT4a-c, and 1,767 (86.4%) T1–3 tumors were registered in GeparTRIO within 36 months. Patients with inoperable/operable tumors had a median age of 53.9/49.0 years, median cT size: 7.0/4.0cm, cN+: 75.6/52.0%, ductal: 76.3/78.4%, lobular: 14.0/13.5%, multiple lesions: 28.5/19.5%, grade 3: 34.8/39.9%, hormone receptor (HR) neg: 24.7/36.6%, HER-2 pos: 41.0/35.5%. Response rates for T4d, T4a-c, T1–3 were 8.4, 10.9, 17.5% (pCR, p=0.007), 36.7, 59.4, 72.6% (palpation after 2 cycles TAC, p<0.0001), 64.2, 62.3, 77.8% (palpation before surgery, p<0.0001), 52.6, 51.9, 67.4% (ultrasound before surgery, p<0.0001). BCT was performed in 12.6, 31.7, 69.5% (p<0.0001). Response after two cycles, negative HR content, young age, high grade, ductal type, but not tumor stage or size, were independent predictors for pCR in the total population. Conclusions: Inflammatory and cT4a-c breast carcinomas, compared to cT1–3 tumors, show less favorable tumor characteristics but a comparable pattern of response to TAC/NX. These patients do not need separate neoadjuvant trials. [Table: see text]

Randomized Trial of 3-Hour Versus 24-Hour Infusion of High-Dose Paclitaxel in Patients With Metastatic or Locally Advanced Breast Cancer: National Surgical Adjuvant Breast and Bowel Project Protocol B-26

1999 ◽  
Vol 17 (11) ◽  
pp. 3403-3411 ◽  
Author(s):  
Roy E. Smith ◽  
Ann M. Brown ◽  
Eleftherios P. Mamounas ◽  
Stewart J. Anderson ◽  
Barry C. Lembersky ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Tumor Response ◽  
Response Rate ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
High Dose ◽  
Hematologic Toxicity ◽  
Event Free Survival ◽  
Free Survival ◽  
Grade 3

PURPOSE: Paclitaxel is an active drug for the treatment of breast cancer; however, the appropriate duration of administration is unknown. We assessed and compared the response rate, event-free survival, survival, and toxicity of paclitaxel 250 mg/m2 delivered every 3 weeks as a 3-hour or 24-hour infusion. PATIENTS AND METHODS: A total of 563 women with stage IV or IIIB breast cancer were randomized into one of two groups: 279 received 3-hour paclitaxel and 284 received 24-hour paclitaxel. Patients were stratified by age, stage of disease, and prior therapy. RESULTS: A significantly higher rate of tumor response occurred in the first four cycles of therapy in patients who received the 24-hour infusion of paclitaxel (51% v 41%, respectively; P = .025). Tumor response over all cycles was also significantly higher in the group that received 24-hour infusion (54% v 44%, respectively; P = .023). There were no significant differences in event-free survival or survival between the two arms of the study (P = .9 and .8, respectively). No treatment by stage or by age interactions were observed. During the first four cycles of therapy, at least one episode of ≥ grade 3 toxicity (excluding nadir hematologic values, alopecia, and weight change) occurred in 45% of patients who received the 3-hour paclitaxel infusion and in 50% of those who received the 24-hour paclitaxel infusion. Febrile neutropenia, ≥ grade 3 infection, and ≥ grade 3 stomatitis were less frequent, and severe neurosensory toxicity was more frequent in those who received the 3-hour paclitaxel infusion. Ten treatment-related deaths occurred in the first four cycles. Age, stage, and prior chemotherapy did not influence the effect of treatment. CONCLUSION: When administered as a continuous 24-hour infusion, high-dose paclitaxel results in a higher tumor response rate than when administered as a 3-hour infusion but does not significantly improve event-free survival or survival. Paclitaxel as a 24-hour infusion results in increased hematologic toxicity and decreased neurosensory toxicity.

Bevacizumab beginning concurrently with a sequential regimen of doxorubicin and cyclophosphamide followed by docetaxel and capecitabine as neoadjuvant therapy followed by postoperative bevacizumab alone for women with HER2-negative locally advanced breast cancer (LABC): A phase II trial of the NSABP Foundation Research Group

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 584-584
Author(s):  
P. Rastogi ◽  
M. Buyse ◽  
S. Swain ◽  
S. Jacobs ◽  
A. Robidoux ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Response ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Pathologic Complete Response ◽  
Metastatic Breast ◽  
Complete Response ◽  
Er Positive ◽  
Grade 3 ◽  
Pathologic Complete Response Rate

584 Background: Bevacizumab with chemotherapy improves outcomes in patients with metastatic breast cancer. The purpose of this trial was to determine the activity and safety profile of bevacizumab with chemotherapy in women with LABC. Methods: Between November 2006 and August 2007, 45 women with HER-2 negative LABC initiated preoperative standard AC x 4 followed by docetaxel 75 mg/m2 IV and capecitabine 825 mg/m2 BID days 1–14 (TX) every 21 days for 4 cycles. Bevacizumab 15 mg/kg IV was given concurrently with chemotherapy every 21 days for a total of 6 preoperative doses. Postoperatively, bevacizumab was resumed for a total of 10 doses. Primary endpoint was pathologic complete response rate (pCR) in the breast. The secondary endpoints include clinical response rates and toxicity. Results: The median age was 50 yrs (range 30–78). 30 patients had stage IIIA (67%), 12 stage IIIB (27%), and 3 stage IIIC (7%) disease. Of these, 10 (22%) had inflammatory breast cancer. 27 patients (60%) had ER-positive disease. A pCR in the breast was documented in 4/44 (9%) patients, which included negative axillary nodes. A complete clinical response was noted in 14/45 (31%). One patient did not have surgery due to progression. Toxicities included hand-foot (grade 2/3–33%/22%), mucositis (grade 2/3–49%/27%), and febrile neutropenia (grade 3–24%). Conclusions: This regimen demonstrated only modest activity with substantial toxicity, and does not appear to warrant further evaluation. This clinical trial is being conducted through the support of Genentech and Roche. [Table: see text]

Preoperative Twice-Weekly Paclitaxel With Concurrent Radiation Therapy Followed by Surgery and Postoperative Doxorubicin-Based Chemotherapy in Locally Advanced Breast Cancer: A Phase I/II Trial

2003 ◽  
Vol 21 (5) ◽  
pp. 864-870 ◽  
Author(s):  
Silvia C. Formenti ◽  
Matthew Volm ◽  
Kristin A. Skinner ◽  
Darcy Spicer ◽  
Deidre Cohen ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Advanced Breast Cancer ◽  
Locally Advanced Breast Cancer ◽  
Locally Advanced ◽  
Radical Mastectomy ◽  
Primary Treatment ◽  
Advanced Breast ◽  
Weekly Paclitaxel ◽  
Modified Radical Mastectomy ◽  
Grade 3

Purpose: Preoperative chemotherapy is the conventional primary treatment in locally advanced breast cancer (LABC). We investigated the safety and efficacy of primary twice-weekly paclitaxel and concurrent radiation (RT) before modified radical mastectomy followed by adjuvant doxorubicin-based chemotherapy. Patients and Methods: Stage IIB (T3N0) to III LABC patients were eligible. Primary chemoradiation consisted of paclitaxel, 30 mg/m2 delivered intravenously for 1 hour twice weekly for a total of 8 to 10 weeks, and concurrent RT (45 Gy at 1.8 Gy/fraction). Modified radical mastectomy was performed at least 2 weeks after completion of chemoradiation or on recovery of skin toxicity. Postoperatively, patients who responded to paclitaxel and RT received four cycles of doxorubicin/paclitaxel, whereas patients who did not respond received doxorubicin/cytoxan. Results: Forty-four patients were accrued. Toxicity from paclitaxel/RT included grade 3 skin desquamation (7%), hypersensitivity (2%), and stomatitis (2%). Postsurgery complications occurred in six patients (14%). The only grade 4 toxicity of postmastectomy chemotherapy was hematologic (10%). Grade 3 toxicities were leukopenia (24%), infection (22%), peripheral neuropathy (17%), arthralgia and pain (17%), stomatitis (12%), fatigue (10%), esophagitis (5%), and nausea (2%). Overall clinical response rate to preoperative paclitaxel and RT was 91%. Thirty-four percent of patients achieved a pathologic response in the mastectomy specimen: 16% pathologic complete responses (clearance of invasive cancer in the breast and axillary contents) and 18% pathologic partial responses (< 10 residual microscopic foci of invasive breast cancer). Conclusion: Twice-weekly paclitaxel with concurrent RT is a feasible and effective primary treatment for LABC. Future studies should compare primary chemoradiation to chemotherapy in LABC.

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